510(k) K250085

On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System by ACON Laboratories, Inc. — Product Code NBW

K250085 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System". The FDA issued a decision of Substantially Equivalent on October 10, 2025. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.